Validation Engineer

Bristol Myers Squibb; Summit (NJ); On-site; USD 125,000 - 150,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a CSV Engineer responsible for supporting the implementation of manufacturing and laboratory systems at multi-use sites. This role involves ensuring compliance with validation and qualification standards, developing documentation, and providing customer service while working in a dynamic team environment.

Benefits

Comprehensive health coverage

Dental and vision benefits

401(k) plan with no matching

Referral bonus program

Qualifications

• Required BS degree in Engineering / Computer Science.
• Minimum 5 years of experience in FDA-regulated industry.
• 3 years’ experience in CSV.

Responsibilities

• Maintains qualified and validated equipment and systems.
• Develops protocols and supports equipment qualification.
• Manages projects of varying scope and complexity.

Skills

Communication

Analytical Skills

Technical Writing

Attention to Detail

Education

BS degree in Engineering / Computer Science

Tools

MS Windows

Microsoft Office Suite

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from Bristol Myers Squibb

The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Responsibilities:

• Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.

• Develops protocols, and associated reports while adhering to a change management process.

• Supports the execution of equipment qualifications and validation protocols.

• Supports calibration, equipment qualification and validation activities.

• Configures and documents the configuration of computerized systems.

• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.

• Manages projects of varying scope and complexity.

• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.

• Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

• Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.

• Provides excellent customer service and support.

• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.

• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Environmental Conditions:

• Environment may include working in office or in a laboratory / manufacturing area.

• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.

• Ability to work safely when working alone or working with others.

Knowledge, Skills, and Abilities:

• Strong working knowledge of MS Windows client and server technologies.

• Working knowledge of standard networking principles and technologies.

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.

• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.

• Ability to work with the end user to identify and document User and Functional Requirements.

• Knowledge of pharmaceutical laboratory and manufacturing systems.

• Ability to interact effectively with laboratory, QA, and Facilities groups.

• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.

• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors. Experience with technical writing and document development / generation.

• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

• Technical / Professional Knowledge

• Attention to Detail

Education and Experience:

• Required BS degree in Engineering / Computer Science

• Minimum 5 years of experience in FDA-regulated industry, with 3 years’ experience in CSV

Locations:

Warren, NJ

Summit, NJ

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.

The starting hourly compensation for this assignment is the following range ($75-$77.01/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.

About ASK Consulting

ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes—across IT, healthcare, engineering, finance, and more—with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.

ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

Equal Opportunity Employer

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

California Applicant Notice

ASK Consulting is committed to complying with the California Privacy Rights Act (“CPRA”), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting [e-mail].

If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local “Fair Chance” ordinances and laws—such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)—we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.

To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.

This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered “at will,” regardless of the expected assignment duration.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Bristol Myers Squibb by 2x

Get notified about new Validation Engineer jobs in Summit, NJ.

Piscataway, NJ $60,789.00-$88,667.00 4 weeks ago

Rahway, NJ $80,000.00-$90,000.00 2 weeks ago

Piscataway, NJ $65,000.00-$75,000.00 3 weeks ago

Rahway, NJ $100,000.00-$115,000.00 1 week ago

Senior Quality Engineer (Aerospace Manufacturing)

New York, NY $69,661.00-$120,000.00 1 day ago

Want to work with us, but don't see the right job listed?

Piscataway, NJ $107,000.00-$150,000.00 1 day ago

ENGINEER, QUALITY (Aerospace), AS9100/FAA Part 145 QMS

Springfield, NJ $90,000.00-$115,000.00 1 week ago

Springfield, NJ $90,000.00-$115,000.00 1 week ago

Engineer, Quality Assurance (Continuous Improvement)

New York City Metropolitan Area 5 hours ago

Rutherford, NJ $94,600.00-$142,000.00 1 week ago

West Caldwell, NJ $96,800.00-$114,100.00 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.